The Immunologic Effect of Early Intravenous Two and Four Gram Bolus Dosing of Tranexamic Acid Compared to Placebo in Patients With Severe Traumatic Bleeding (TAMPITI): A Randomized, Double-Blind, Placebo-Controlled, Single-Center Trial.
hemostasis
immunology
monocyte activation
tranexamic acid
trauma
Journal
Frontiers in immunology
ISSN: 1664-3224
Titre abrégé: Front Immunol
Pays: Switzerland
ID NLM: 101560960
Informations de publication
Date de publication:
2020
2020
Historique:
received:
13
04
2020
accepted:
30
07
2020
entrez:
5
10
2020
pubmed:
6
10
2020
medline:
29
4
2021
Statut:
epublish
Résumé
The hemostatic properties of tranexamic acid (TXA) are well described, but the immunological effects of TXA administration after traumatic injury have not been thoroughly examined. We hypothesized TXA would reduce monocyte activation in bleeding trauma patients with severe injury. This was a single center, double-blinded, randomized controlled trial (RCT) comparing placebo to a 2 g or 4 g intravenous TXA bolus dose in trauma patients with severe injury. Fifty patients were randomized into each study group. The primary outcome was a reduction in monocyte activation as measured by human leukocyte antigen-DR isotype (HLA-DR) expression on monocytes 72 h after TXA administration. Secondary outcomes included kinetic assessment of immune and hemostatic phenotypes within the 72 h window post-TXA administration. The trial occurred between March 2016 and September 2017, when data collection ended. 149 patients were analyzed (placebo, In trauma patients with severe injury, 4 g intravenous bolus dosing of TXA has minimal immunomodulatory effects with respect to leukocyte phenotypes and circulating cytokine levels. www.ClinicalTrials.gov, identifier NCT02535949.
Sections du résumé
Background
The hemostatic properties of tranexamic acid (TXA) are well described, but the immunological effects of TXA administration after traumatic injury have not been thoroughly examined. We hypothesized TXA would reduce monocyte activation in bleeding trauma patients with severe injury.
Methods
This was a single center, double-blinded, randomized controlled trial (RCT) comparing placebo to a 2 g or 4 g intravenous TXA bolus dose in trauma patients with severe injury. Fifty patients were randomized into each study group. The primary outcome was a reduction in monocyte activation as measured by human leukocyte antigen-DR isotype (HLA-DR) expression on monocytes 72 h after TXA administration. Secondary outcomes included kinetic assessment of immune and hemostatic phenotypes within the 72 h window post-TXA administration.
Results
The trial occurred between March 2016 and September 2017, when data collection ended. 149 patients were analyzed (placebo,
Conclusion
In trauma patients with severe injury, 4 g intravenous bolus dosing of TXA has minimal immunomodulatory effects with respect to leukocyte phenotypes and circulating cytokine levels.
Clinical Trial Registration
www.ClinicalTrials.gov, identifier NCT02535949.
Identifiants
pubmed: 33013880
doi: 10.3389/fimmu.2020.02085
pmc: PMC7506112
doi:
Substances chimiques
IL6 protein, human
0
Interleukin-6
0
SELL protein, human
0
L-Selectin
126880-86-2
Tranexamic Acid
6T84R30KC1
Banques de données
ClinicalTrials.gov
['NCT02535949']
Types de publication
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.
Langues
eng
Sous-ensembles de citation
IM
Pagination
2085Subventions
Organisme : NIGMS NIH HHS
ID : R35 GM133756
Pays : United States
Investigateurs
M D Enyo Ablordeppey
(MD)
M P H James Fehr
(MPH)
M D Philip Miller
(MD)
M D George Despotis
(MD)
M D Melanie Fields
(MD)
M D Kevin Ward
(MD)
Informations de copyright
Copyright © 2020 Spinella, Thomas, Turnbull, Fuchs, Bochicchio, Schuerer, Reese, Coleoglou Centeno, Horn, Baty, Shea, Meledeo, Pusateri, Levy, Cap and Bochicchio.
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